• Daiichi Sankyo, Inc. (Bernards, NJ)
    …product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences for oncology… more
    HireLifeScience (01/03/25)
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  • Merck & Co. (Rahway, NJ)
    …team environment with key stakeholders across the organizations such as Quality, Regulatory CMC , and technical functions, to ensure timebound progression of ... have solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations, Non-clinical, Clinical, and… more
    HireLifeScience (02/12/25)
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  • Senior Director , CMC Product…

    AbbVie (North Chicago, IL)
    …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director of CMC Product Development will use their ... CMC activities with respect to science, technology, quality, regulatory /compliance requirements, budget and resources. + Multiple product development experiences… more
    AbbVie (02/13/25)
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  • Associate Director , CMC Lead

    Daiichi Sankyo Inc. (Basking Ridge, NJ)
    …product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... preferred - 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences for oncology… more
    Daiichi Sankyo Inc. (01/22/25)
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  • Regional Medical Director , CMC

    UTMB Health (Gatesville, TX)
    Regional Medical Director , CMC **Gatesville, Texas, United States** Physician UTMB Health Requisition # 2500313 The mission of Correctional Managed Care is to ... responsibility for all medical providers assigned within the region. Works under the director of the senior medical director . **_ESSENTIAL JOB FUNCTIONS_**… more
    UTMB Health (01/24/25)
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  • Senior Director - Analytical…

    Gilead Sciences, Inc. (Foster City, CA)
    …more than 35 countries worldwide, with headquarters in Foster City, California._ ** Senior Director - Analytical Regulatory ** **Science** **KEY** ... **RESPONSIBILITIES** The Sr Director , Analytical Regulatory Science, is responsible for supervising a team of...leading the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure… more
    Gilead Sciences, Inc. (12/03/24)
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  • Senior Director Global…

    Lilly (Indianapolis, IN)
    …wage for this position is $162,000 - $237,600 **Purpose:** The purpose of the Senior Director , Global Regulatory Affairs, Global Regulatory Lead ... development experience for 10 years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable therapeutic area + Knowledge of Global… more
    Lilly (02/07/25)
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  • Director , Regulatory Affairs

    Sumitomo Pharma (Springfield, IL)
    …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs** . The Director is part of the ... (GRA) team based in the US. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects.… more
    Sumitomo Pharma (11/28/24)
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  • Director , Regulatory Affairs: Job…

    Ascendis Pharma (Palo Alto, CA)
    …and those of direct reports. + Work is performed under direction of a Senior Regulatory Affairs professional. + Contribute to internal regulatory policies ... for employees to grow and develop their skills. The Director , Regulatory Affairs will be responsible for...Affairs will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC more
    Ascendis Pharma (12/10/24)
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  • Senior Director Clinical Development…

    Teva Pharmaceuticals (Parsippany, NJ)
    …documents (ie protocols, Investigator's Brochures, clinical study reports, summaries for regulatory submissions). The Senior Director , Clinical Development ... Senior Director Clinical Development - Respiratory...working closely with other functional areas such as commercial, regulatory , pharmacovigilance, CMC , early clinical and pre-clinical… more
    Teva Pharmaceuticals (01/22/25)
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  • Associate Director , Business Development…

    AbbVie (North Chicago, IL)
    …with internal and external stakeholders. + Stay updated on global CMC technical, regulatory , compliance developments, and industry practices. Qualifications ... Facebook, Instagram, YouTube and LinkedIn. Job Description As an Associate Director , Operations Strategy and Pipeline Leadership (OSPL) within the Product… more
    AbbVie (02/12/25)
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  • Senior Director , PDM Product…

    Gilead Sciences, Inc. (Foster City, CA)
    …in more than 35 countries worldwide, with headquarters in Foster City, California. ** Senior Director , PDM Product Strategy Leader** **Foster City, CA** **KEY ... in some aspects of pharmaceutical manufacturing, or supply chain, or quality, or CMC regulatory , or process development, or as part of a cross-functional… more
    Gilead Sciences, Inc. (02/07/25)
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  • Senior Director , CMO…

    BeiGene (San Mateo, CA)
    **General** **Description:** The Senior Director of CMO and Distribution Logistics, Clinical Supply Chain is responsible for overseeing the Clinical Supply Chain ... functional leadership (including but not limited to clinical Operation, Quality, Regulatory , CMC , and GRDS) to ensure alignment of organizations and prompt… more
    BeiGene (12/12/24)
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  • Senior Director of Clinical…

    Hartford HealthCare (Southington, CT)
    …Center* **Title:** * Senior Director of Clinical Services, Senior Services* **Location:** *Connecticut-Southington-80 Meriden Ave Southington CMC (10209)* ... we offer premier physical, occupational and speech therapies. Position Summary: The Senior Director of Clinical Services will provide leadership and clinical… more
    Hartford HealthCare (01/29/25)
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  • Director , Regulatory Affairs Data…

    Gilead Sciences, Inc. (Foster City, CA)
    … affairs organization. The incumbent will collaborate with patient safety, quality, regulatory CMC , commercial, clinical, and other development organizations on ... create possible, together. **Job Description** The Data Governance Lead for Regulatory Affairs will be responsible for defining, implementing, and overseeing data… more
    Gilead Sciences, Inc. (12/20/24)
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  • Senior Director of External Quality…

    Gilead Sciences, Inc. (Foster City, CA)
    …of safe life-changing therapies. **Job Summary:** Gilead Sciences is currently seeking a Senior Director level position to be the leader of Packaging Quality ... leaders in in Portfolio Strategy team, Manufacturing, Packaging, Supply Chain, Regulatory CMC , and the wider PDM Quality organization to achieve business… more
    Gilead Sciences, Inc. (01/17/25)
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  • Senior Director , Clinical…

    Bristol Myers Squibb (San Diego, CA)
    …entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals . The Senior Director - Clinical Pharmacology will be a key member of the ... with the development strategy, program goals, and the US/international regulatory guidance for radiopharmaceuticals. + Collaborate with DMPK, clinical development,… more
    Bristol Myers Squibb (02/09/25)
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  • Director , Biological Research/…

    AbbVie (Irvine, CA)
    …Neurotoxin Research Group at AbbVie seeks an accomplished scientist and leader. The Director / Senior Principal Research Scientist will lead a team performing in ... productive, collaborative, and inclusive laboratory environment in compliance with regulatory and company expectations. Experience managing projects from early-stage… more
    AbbVie (12/19/24)
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  • Senior Director , Global Program…

    Takeda Pharmaceuticals (Boston, MA)
    …company that will inspire you and empower you to shine? Join us as a Senior Director , Global Program Leader (GPL) in our Cambridge office. At Takeda, we ... experienced, versatile and strong enterprise leaders + Committed to simultaneously driving regulatory approval as well as launch and global patient access + Ability… more
    Takeda Pharmaceuticals (02/15/25)
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  • Director : Vaccine Drug Product Development…

    Merck (West Point, PA)
    …team environment with key stakeholders across the organizations such as Quality, Regulatory CMC , and technical functions, to ensure development of robust ... regulatory posture + Demonstrated working knowledge of FDA, ICH, and other regulatory requirements for CMC . Strong experience in safety and environmental… more
    Merck (02/04/25)
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